RENEWAL APPLICATION FORM
URGENT UPDATE:
The IRB will no longer accept Renewal Applications
after a protocol expires.
There will be no “grace
period” for a Renewal Application received after
the Expiration Date of the protocol.
The UMCP IRB and Federal
Regulations do not permit extensions of human
subject research projects beyond the IRB Approval
dates.
If you would like to continue
obtaining data from human subjects or collecting or
analyzing identifiable private information for a
human subjects research project, a Renewal
Application must be reviewed and approved by the
Institutional Review Board (IRB) prior to the
expiration date for the previous IRB approval.
However, if the Renewal
Application is submitted prior to the Expiration
Date this does not guarantee the application will
receive IRB Approval before the protocol expires.
If the protocol does
expire after a Renewal Application has been
submitted, all research activities involving human
subjects must cease until approval is granted. If a Renewal Application is not received by the
IRB Office prior to the Expiration Date, the
protocol will expire and a New (Initial) Protocol
Application must be submitted and approved in order
to continue human subject research activities.
Determining if Renewal is Required
Please consider the following
questions when determining if a Renewal Application
or Closure Report must be submitted.
If you have any
questions, please contact the IRB Office.
1) Will future
research activities involve obtaining data through
intervention or interaction with human subjects?
2)
Will future research activities involve obtaining
identifiable private information about living
individuals? Information is identifiable if subjects
can be identified directly or through identifiers
linked to the subjects.
This includes any lists
of participants that have not yet been destroyed.
3) Will future
research activities include analyzing identifiable
private information about living individuals?
PLEASE NOTE:
If you answered yes to any of these 3 questions, a
Renewal Application must be submitted for your
research project.
If
you answered no to all of the above questions, a
Renewal Application is not required and a Closure
Report must be submitted.
A protocol is eligible
for closure if:
a) data collection is
complete
b) there is no more participant
contact (including follow-up interviews, calls,
surveys)
c) the only research activity
remaining is data analysis of de-identified data.
Please
click here to submit a Closure Report:
Closure Report Form
Download Renewal Application
Form
Download Consent Form
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